Highlights:
- Neurizon announces an expansion to the size of Regimen I intended to support a larger and more informative dataset, with accelerated time to topline readout and no change in funding requirements
- Increase in sample size driven by enrolment rate exceeding original expectations and the absence of a concurrent regimen during the expected recruitment period
- Regimen I expands from 160 to 240 participants to maintain statistical power for the primary endpoint aligned with the original trial assumptions
- The increased sample size allows more robust analysis of subgroups and biomarkers and ensures a fully powered study at topline results
- Based on current enrolment momentum, Neurizon anticipates that last participant dosing will now occur in Q2 CY2027 with topline results to be released early Q3 CY2027, exceeding previous trial timeframe projection
- Expanded participant cohort cost is materially offset by a contribution of philanthropic funds from the Sean M. Healey & AMG Center for ALS at Mass General Brigham
- As a result of diligent cost management and rapid recruitment, this change is expected to have no impact on Neurizon's costs through to topline results and only a very modest increase in the total cost of completing the full trial
- Larger, consistent dataset expected to strengthen partnering and commercial positioning for NUZ-001
- 113 participants assigned and 74 dosed as of 22 May 2026, with 64 US clinical trial sites activated and 193 participants screened under the master protocol to date
- Neurizon to host a shareholder webinar on 28 May to discuss the trial recruitment expansion in further detail
MELBOURNE, Australia, May 27, 2026 /PRNewswire/ -- Neurizon® Therapeutics Limited (ASX: NUZ & NUZOA; OTCQB: NUZTF) ("Neurizon" or "the Company"), a clinical-stage biotech company dedicated to advancing innovative treatments for neurodegenerative diseases, is pleased to advise that Regimen I of the HEALEY ALS Platform Trial will increase its total patient cohort from 160 to 240 participants. The expansion is driven by the enrolment rate exceeding original expectations and the absence of a concurrent regimen during the expected recruitment period. Expanded design maintains statistical power for the primary endpoint aligned with the original assumptions underpinning the study and allows more robust analysis of subgroups and biomarkers.
Importantly, the current recruitment momentum is expected to accelerate the overall trial timeline relative to previous expectations, despite the increased recruitment target. Based on current trends, the Company now anticipates last participant dosing in Q2 CY2027, with topline results expected in early Q3 CY2027.
Following an extensive review of the scientific, statistical, financial and regulatory considerations, as well as ongoing engagement with the Sean M. Healey & AMG Center, Regimen I will now comprise 180 NUZ-001 participants and 60 Regimen I placebo controls.
As of 22 May 2026, 113 participants have been assigned to Regimen I and 74 participants have been dosed. There are 64 clinical trial sites activated across the United States and 193 participants have been screened to date under the master protocol. While current recruitment momentum continues to track ahead of prior expectations, future recruitment rates may vary over time.
Based on the expanded 240-patient design, accelerated enrolment timelines and a meaningful financial contribution of philanthropic funds from the Sean M. Healey & AMG Center for ALS at Mass General Brigham, Neurizon expects the total funding requirements through to study completion to remain unchanged.
Neurizon remains focused on efficiently delivering a scientifically meaningful outcome from the HEALEY ALS Platform Trial. The expansion of the trial has no impact on Neurizon's expected costs through to topline results, with only a modest overall increase in the total cost of completing the full trial. This increase is expected to be further offset through eligibility under the Australian Federal Government's R&D Tax Incentive Program, together with the financial contribution of philanthropic funds from the Sean M. Healey & AMG Center for ALS at Mass General Brigham. This demonstrates Neurizon's continued focus on cost and capital efficiency and ensures the Company remains fully funded through completion of the trial.
Neurizon believes expanding the regimen is a fiscally disciplined and strategically attractive decision to generate a larger, more statistically robust, and internally consistent ALS dataset, which eliminates reliance on placebo groups from other regimens and maintains the original statistical assumptions underpinning the study at topline results.
Interim Executive Chairman, Mr Sergio Duchini said: "The expansion of Regimen I to 240 participants reflects our considerable confidence in NUZ-001 and is underpinned by strong momentum being delivered across the HEALEY ALS Platform Trial study. Importantly, this decision maintains the statistical power for the analysis of the primary endpoint and the potential for topline results ahead of our previously stated schedule."
"The strength of recruitment and engagement across the HEALEY ALS Platform Trial network has positioned Neurizon to proactively optimise the study design at an important point in the trial. We believe the expanded dataset will strengthen the statistical robustness, interpretability and strategic value of the program as we advance toward topline results."
"Importantly, the larger and more internally consistent dataset is expected to enhance future regulatory, partnering and commercial opportunities for NUZ-001, while also strengthening our ability to generate valuable biomarker and translational insights relevant to the broader neurodegenerative disease landscape."
"ALS remains an area of urgent unmet medical need, and we believe this decision further strengthens Neurizon's positioning as we continue advancing NUZ-001 through late-stage clinical development."
Merit Cudkowicz, MD, MSc, Director of the Healey & AMG Center and Executive Director of the Mass General Brigham Neuroscience Institute, said: "This partnership with Neurizon reflects a shared commitment to advancing meaningful science while keeping people living with ALS at the center of everything we do. We thank our patient advisory committee members and the entire ALS community for active participation in this important clinical trial. By working collaboratively, we can accelerate progress, strengthen the research ecosystem, and ultimately deliver solutions that better serve the ALS community."
Sabrina Paganoni, MD, PhD, Co-Principal Investigator of the HEALEY ALS Platform Trial and Co-Director of the Neurological Clinical Research Institute (NCRI) said: "I want to sincerely thank the Network of Excellence for ALS (NEALS) investigators and site teams for achieving our most rapid enrollment to date — an extraordinary milestone that reflects their dedication and collaboration. I also want to recognize the coordination center at the Healey & AMG Center and key vendors for outstanding implementation and execution of the study, which made this success possible, as well as participants and their families for their dedication and support."
About the HEALEY ALS Platform Trial:
The HEALEY ALS Platform Trial (ClinicalTrials.gov identifier: NCT04297683) is a multicentre, double-blind, placebo controlled adaptive Phase 2/3 clinical trial conducted by the Sean M. Healey & AMG Center for ALS at Mass General Brigham in the United States (US), created in partnership with the Network of Excellence for ALS (NEALS). Entry into the HEALEY ALS Platform Trial is competitive, with drug candidates reviewed and selected by expert committees based on scientific merit and evidence of potential benefit in ALS. The goal of the HEALEY ALS Platform Trial is to accelerate the development of potential new ALS therapies.
This announcement has been authorised for release by the Board of Neurizon Therapeutics Limited.
About Neurizon Therapeutics Limited
Neurizon Therapeutics Limited (ASX: NUZ) is a clinical-stage biotechnology company dedicated to advancing treatments for neurodegenerative diseases. Neurizon is developing its lead drug candidate, NUZ-001, for the treatment of ALS, which is the most common form of motor neurone disease. Neurizon's strategy is to accelerate access to effective ALS treatments for patients while exploring the potential of NUZ-001 for broader neurodegenerative applications. Through international collaborations and rigorous clinical programs, Neurizon is dedicated to creating new horizons for patients and families impacted by complex neural disorders. NUZ-001 is an investigational product and is not approved for commercial use in any jurisdiction.
Neurizon® is a registered trademark of Neurizon Therapeutics Limited
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HEALEY ALS Platform Trial Regimen I expands to 240 participants
New updates shed light on Tencent Games' long-term commitment to providing advanced interactive digital experiences for users worldwide
SHENZHEN, China, May 27, 2026 /PRNewswire/ -- Tencent Games shared 45 major updates for both the Chinese and global markets today at its annual SPARK 2026 conference. Across the three key categories - Development, Publishing and Investments - the showcase highlighted major gameplay and content updates, upcoming new IP collaborations and cross-platform, audio-visual experiences powered by technological innovation, reinforcing Tencent Games' position as a global leader in game development, publishing and operations.
SPARK 2026 this year brings together both new and veteran gamer communities to celebrate creativity, innovation and the evolving future of gaming, shaped by technological advancement and the long-term strategy of Tencent Games, focusing on expanding its global IP portfolio, delivering high-quality and immersive experiences both within and beyond games to players around the world.
Below is a snapshot of key updates from SPARK 2026:
Arcane Immersive Show
The world's first League of Legends live interactive experience is now playing in Shanghai. Overseen by Riot Games and co-produced by Tencent Video, Tencent Games, Shanghai Media Group (SMG) Live, and Wajijiwa Entertainment, the show is co-created by world-renowned immersive theatre company Punchdrunk. In 120 minutes, audience can walk through life-sized sets of Piltover and Zaun, follow Jinx or Vi up close, and enjoy over 30 live songs including "Enemy". Tickets for shows before August 31 are on sale now on Trip.com, with over 100 upgraded performances awaiting this summer.
Arena Breakout: Infinite
Arena Breakout: Infinite is showcased at SPARK 2026 with its Season 5: Distortion available at the moment, launching with the Distorted Valley mode, granting operators with four unique abilities, as well as PvE mode No Man's Land, Warlord Tournament, and Boss Rally. The season promises the game's most transformative content update yet. Arena Breakout: Infinite is a high-stakes tactical extraction shooter - fight, loot, and extract, or lose it all. With realistic visuals, lifelike sound, and unforgiving PvPvE combat, every raid is a gamble between glory and ruin.
Arma Reforger
The authentic military simulator sandbox game Arma Reforger from Bohemia Interactive announced its latest Version 1.6, which introduces a dedicated single-player campaign experience called "Operation Omega". It also features a free new map, "Kolguyev," offering rugged terrain for unique PvP and PvE scenarios. Additionally, the upcoming Version 1.7 will make the FIA Resistance a newly playable faction.
Animula Nook
Animula Nook is a Lilliput fantasy life sim that has surpassed 8 million registrations globally ahead of its official launch. Showcased at SPARK 2026, the Insoul - a new race of Minies - was unveiled for the next test, alongside major upgrades to the Minies' action, social, and memory systems. The game is now planned for PC, PS5, Switch 2, and soon will support macOS. Pre-register now on https://animulanook.com/en/ !
Call of Duty: Mobile
At SPARK 2026, Call of Duty: Mobile announced a major collaboration with Persona 5 Royal for July. The developing team also pledged ongoing optimizations on matchmaking system and user experience, alongside a lineup of offline community events in China throughout this summer. Stay tuned!
Chaos Zero Nightmare
The cosmic dark fantasy roguelite deck-building card game, Chaos Zero Nightmare will officially launch on May 28 in the Chinese mainland. The game is developed by SUPER CREATIVE, a studio under game developer Smilegate, and published by Tencent Games. Chinese players will get an exclusive early access experience of Fei, a character steeped in Eastern mysticism. Players can build their own powerful custom decks, with a wealth of brand-new gameplay content launching simultaneously.
CONTROL Resonant
Developed by Finnish studio Remedy Entertainment, CONTROL Resonant is an action RPG set to launch on PC and consoles in 2026. As the Remedy's most extensively localized game to date, the upcoming CONTROL Resonant will feature full Simplified Chinese voice-over, interface, and subtitles. Players step into the role of Dylan Faden and explore a transformed Manhattan where an invading cosmic force has twisted reality, gravity, and the laws of nature. Journey through surreal environments, master powerful supernatural abilities, shape your own playstyle through deep character progression, and wield the shape-shifting weapon known as the Aberrant.
Cosmo Tales
The upcoming retro sci-fi shooter Cosmo Tales officially announced its Early Access will launch this September. In the game, players will drive a vehicle inspired by the famous Škoda 1203, diving into a vibrant universe for an adventure of cosmic exploration and intense combat.
DayZ
Open-world survival classic DayZ from Bohemia Interactive has announced its new "Badlands" expansion. This expansion will introduce a brand-new frontier environment and marks DayZ's largest map to date, spanning a total area of 267 square kilometers.
Delta Force
At SPARK 2026, Delta Force officially announced its collaboration with the Jingdezhen Imperial Kiln Institute, bringing one of China's most iconic porcelain traditions into its global tactical shooter universe. Through the collaboration, rare imperial kiln porcelain treasures will be digitally recreated as collectible "Big Red" items within the game, beginning with Ducktor Sui, a restored Ming Chenghua sancai duck-shaped incense burner and one of the institute's signature cultural icons. The collaboration is designed to translate Jingdezhen's craftsmanship, history, and cultural spirit into Delta Force's interactive world, allowing global player community to discover and collect China's heirloom porcelain treasures in a new digital form.
Digital Jingdezhen
Digital Jingdezhen: Porcelain Craft Adventure, jointly developed by Tencent Games, Tencent SSV Digital Culture Lab, Jingdezhen Municipal Bureau of Culture and Tourism, Jingdezhen Imperial Kiln Institute and Jingdezhen Municipal Office for World Heritage Nomination and Conservation, made its official debut at the launch event.
As the first officially licensed simulation game themed on the porcelain industry, Digital Jingdezhen: Porcelain Craft Adventure recreates the flourishing world of Jingdezhen's traditional porcelain production and presents the complete handcrafted porcelain-making process. Through the immersive simulation gameplay, players will begin as apprentices and gradually grow into master kiln owners, managing resources, expanding production capacity, unlocking new technologies, and collecting nearly one hundred renowned ceramic masterpieces from different dynasties. The game offers a comprehensive and immersive journey through the millennium-long evolution of Jingdezhen's porcelain industry.
Built upon the multimodal AI dataset developed for the "Jingdezhen Handicraft Porcelain Industry Sites", the game also incorporates advanced gaming AI technologies, including AI-powered digital humans and AI-generated 3D content. Digital Jingdezhen: Porcelain Craft Adventure is scheduled for release in the third quarter of 2026 in the Chinese mainland.
Era of Ascendancy
Era of Ascendancy is an ink-and-wash Chinese-style free-form cultivation RPG where players choose their own path and shape their story. At SPARK 2026, two new systems were revealed: Dark Cultivation, offering a forbidden path via the Devour ability to seize others' cultivation - with risks; and Mystic Extraction, a Bagua Realm of three escalating layers - break the Bagua Seal, navigate the Five Elements Three Realms, then shatter the Yin-Yang Seal and face the ultimate guardian for the greatest treasures. The game is currently only available in the Chinese mainland.
Everwind
The highly anticipated pixel sandbox game Everwind, launched its Early Access on this March 18th with full Chinese localization. It was revealed that a dedicated team based in China will be responsible for gathering feedback from Chinese players for timely optimizations, as well as help with introduction of Chinese-community specific content. Furthermore, exclusive easter eggs dedicated to Chinese players are waiting to be discovered in-game.
Just Dance: Party
Just Dance: Party is the latest mobile installment of the globally acclaimed Just Dance franchise, offering players a vibrant, joy-filled dance party on the go. The game leverages cutting-edge camera-based motion capture technology on mobile, allowing players to dance anytime, anywhere, with friends or fellow enthusiasts, and immerse themselves in the boundless energy of music and dance. With just a front-facing camera, players can enjoy a truly immersive, full-body dance experience in any setting. Whether a first-time dancer or a seasoned pro, every player can find their rhythm and joy, stay fit, and connect with friends through shared social experiences. Just Dance: Party is set to launch on July 2 in the Chinese mainland.
MagicDawn
MagicDawn launched NDGI (Neural Dynamic Global Illumination) - the world's first cross-platform neural dynamic global illumination solution - and announced it is now fully open-source. Built on real-time neural network inference, NDGI breaks through traditional offline pre-computation bottlenecks, enabling real-time response across all dynamic scene elements. For the launch, MagicDawn partnered with the game IP, Roco Kingdom for enhanced in-game lighting, and collaborated with Arm on deep AI inference optimization for mobile GPUs. With NDGI open-source, developers worldwide can access the complete solution and toolchain.
NIZHAN FUTURE
Nizhan Future, a PVE shooter developed by Tencent TiMi Studio Group's J3 Studio has launched in the Chinese mainland in January 2026. At SPARK 2026, the game unveiled its future roadmap: IP collaborations with Langlang Mountain's Little Monster and Borderlands, along with plans to introduce space combat content. The game is currently only available in the Chinese mainland.
Tides of Annihilation
At SPARK 2026, Eclipse Glow Games announced that Tides of Annihilation will host its first hands-on event this summer. A new technical showcase video detailing the deep engineering partnership with Unreal Engine and NVIDIA - including refined CPU/GPU pipelines, Nanite-based optimization for "Giant Knight" encounters, and NVIDIA path tracing with driver-level optimization. Tides of Annihilation is currently being developed for PC for both Steam and Epic Games Store, Xbox, and PlayStation.
Warframe
The classic sci-fi shooter Warframe officially announced at its showcase that its new update, Jade Shadows: Constellations, is coming soon. The showcase also featured an animated short film that delves into the update's backstory.
SPARK 2026 underscores how Tencent Games continues to advance the future of interactive entertainment through technological innovation, expanding global IP experiences, and immersive, high-quality experiences that connect gaming communities around the world both within and beyond games.
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Tencent Games Spotlights Future Player Experiences with 45 Major Updates at SPARK 2026